- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...Regulatory experience required across various modality types.M.D. or PhD with >20 years relevant experience preferably with >15… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global ... Medical Affairs /MSL training and continued education plans related to Eisai's...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and may… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part of the ... US Medical Affairs team, the Senior Medical Science Liaison (MSL) will...hired MSLs.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.Requirements2-3 years relevant MSL work experience in therapeutic… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Rahway, NJ)
- …is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (North Wales, PA)
- …Product Development Teams, Franchise Teams, Regional Product Directors, affiliates, Public Affairs , and Medical Education to ensure value evidence programs are ... plans for in-line and developmental products based on the regulatory , marketing and reimbursement environments on a worldwide basis,...market access needs in key global markets-5+ years post PhD or 7+ years post Masters degree of relevant… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. Job Description The Senior Director, Regulatory Affairs , Advertising and Promotion is responsible for developing and ... Company, in Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs . Responsibilities: Lead, develop, and mentor a team of regulatory… more
- Fate Therapeutics, Inc. (San Diego, CA)
- Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of ... corporate headquarters in San Diego, CA. Responsibilities Lead the Regulatory Affairs team in effectively working with...set clear goals, delegate tasks, and monitor performance. Qualifications BS/MS/ PhD degree in a life science with at least… more
- BioSpace (Tarrytown, NY)
- Job Details The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with ... typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our San Diego, CA ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making to help transform… more
- BioSpace (Tarrytown, NY)
- Job Details The role leads a group within Regenerons Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron ... across functional areas. As a strategic leader within the Regulatory Affairs organization the incumbent will be...role might be for you if Terminal degree (MD, PhD ,, PharmD, etc.) in a scientific discipline related to… more
- DermBiont (Emeryville, CA)
- …employees to do their best work. Overview: We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join ... with the highest probability of success in the clinic, defining clear regulatory strategies, and conducting efficient clinical trials. DermBiont works continually to… more
